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A prospective single-arm intervention study of individualized treatment strategy of Faricimab in patients with BRVO macular edema

A Prospective Single-Arm Interventional Study of a Fluid-Guided Faricimab Regimen (Monthly to Resolution Followed by PRN) in Treatment-Naïve Macular Edema Secondary To Branch Retinal Vein Occlusion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123708
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-05-04
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Branch Retinal Vein Occlusion

Interventions

Test group:Faricizumab injected monthly until the effusion subsided and treated as needed

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years, regardless of sex; 2. Macular edema secondary to branch retinal vein occlusion (BRVO), confirmed by the investigator based on clinical and imaging findings; 3. Treatment-naïve: the study eye has not received any prior treatment for macular edema; 4. Central subfield thickness (CST) meets the predefined threshold: measured by swept-source OCT, CST >=320 µm; 5. Best-corrected visual acuity (BCVA) within the eligible range: ETDRS letter score between 73 and 19 (equivalent to Snellen 20/40 to 20/400); 6. Availability of clear ocular imaging, including OCT/OCTA, fundus photography, and reliable visual acuity measurements; 7. Only one study eye will be included: if both eyes are eligible, the eye with worse visual acuity will be selected; 8. Ability to comply with the study protocol, complete follow-up visits, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Macular edema in the study eye not caused by BRVO (e.g., diabetic retinopathy, CRVO, etc.); 2. Structural abnormalities in the study eye that may affect retinal thickness or visual acuity assessment, including vitreous hemorrhage, tractional retinal detachment, moderate or severe vitreous opacity, active intraocular inflammation, history of ocular trauma, significant epiretinal membrane, or macular hole; 3. Prior treatments in the study eye that may affect macular structure, including anti-VEGF therapy, intravitreal corticosteroid injection, laser photocoagulation, or vitrectomy; 4. Coexisting ocular diseases in the study eye that may severely affect visual function, such as uveitis, advanced glaucoma (MD < -20 dB), optic atrophy, or ischemic optic neuropathy; 5. Inability to obtain high-quality fundus images in the study eye, due to factors such as abnormal pupil or severe media opacity; 6. History of major cardiovascular or cerebrovascular events within the past 6 months, including myocardial infarction, stroke, or transient ischemic attack; 7. Uncontrolled hypertension (systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg); 8. Bleeding tendency or current use of anticoagulants that cannot be adjusted; 9. Pregnancy or lactation, or plans for pregnancy in the near future; 10. Known hypersensitivity to the study drug components (e.g., Faricimab or its excipients); 11. Inability to comply with scheduled follow-up or study procedures; 12. Participation in another clinical trial that may affect the evaluation of this study within the past 30 days; 13. Any other serious condition judged by the investigator that may increase risk or interfere with study outcomes.

Design outcomes

Primary

MeasureTime frame
Best Corrected Visual Acuity;

Secondary

MeasureTime frame
Central Macular Thickness (CMT);Total Number of Injections;Retinal Vascular Density (RVD);

Countries

China

Contacts

Public ContactYanping Zhou

Zhongshan Hospital, Fudan University

zhou.yanping@zs-hospital.sh.cn+86 135 6497 8493

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026